MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO INSTRUMENT BATTERY; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	6000-006-000
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/23/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during incoming inspection at the user facility a leak was found in the battery.The battery is contained in the hand piece and could not leak onto the patient during a procedure, but the leak could cause the battery to become non functional during a procedure.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a root cause could not be determined for the event.Discarded by user.
Event or Problem Description
It was reported that during incoming inspection at the user facility a leak was found in the battery.The battery is contained in the hand piece and could not leak onto the patient during a procedure, but the leak could cause the battery to become non functional during a procedure.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

• Brand Name: INSTRUMENT BATTERY
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7150727
• Report Number: 0001811755-2017-02506
• Device Sequence Number: 16404839
• Product Code: HAW
• UDI-Device Identifier: 04546540245045
• UDI-Public: (01)04546540245045
• Combination Product (Y/N): N
• PMA/510(K) Number: K993239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6000-006-000
• Device Catalogue Number: 6000006000
• Device Lot Number: 60152376
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1